Ameliorative Potential of Relaxing Back Massage on Puerpe... | NCT06311643

Studies
Ameliorative Potential of Relaxing Back Massage on Puerperial Women's Hormones and Infant Weight

NCT06311643

Sponsor

Kafrelsheikh University

Status

Completed

Last Update Posted

Mar 15, 2024Actual

Enrollment

45Actual

Phase

Phase 2Phase 3

Conditions

Does Postpartum Massage Affect Leptin, Prolactin and Growth Hormone

Interventions

Postpartum back massage in study group

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2, 2023Actual

Primary Completion Date

Sep 1, 2023Actual

Completion Date

Mar 1, 2024Actual

First Submitted Date

Mar 8, 2024

First Submission Date that Met QC Criteria

Mar 8, 2024

First Posted Date

Mar 15, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2024

Last Update Posted Date

Mar 15, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Effect of massage on hormone levels in puerperal women

Detailed Description

Postpartum back massage can effectively increase prolactin, growth hormone levels, which in turn can make the baby's growth more healthy and decrease leptin levels, which can protect the child from future obesity and so, clinicians should advise postpartum women to have massage after delivery.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group	Experimental	Postpartum Back Massage is done to puerperal women just after 4 hours of delivery and for 1 month with rate of 3 sessions per week and routine postnatal care	Other: Postpartum back massage in study group
Control group	No Intervention	Puerperal women just have routine post natal care for 1 month

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Postpartum back massage in study group	Other	Effleurage massage from shoulders toward lower back	Study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Leptin and prolactin levels increase	Increase levels of lactating hormones	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

puerperal women within 4 hours of normal delivery and they are primiparous

Exclusion Criteria:

nulliparous More than 30 years or less than 25 years Chronic diseases Caesarean delivery

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kafrelshiekh university		Kafrelshiekh	Kafrelshiekh	6850001	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Information will be releasid on pub med

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

June 2024 to june 2025

Access Criteria

Not provided

URL

Not provided